Conducting Remote Regulatory Assessments-Questions and Answers; Revised Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled "Conducting Remote Regulatory Assessments--Question and Answers." FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.